Preoperative Counseling in Cholecystectomy

NCT01629992 | Completed Phase 2 DMC

• 2 other identifiers: preopcounseling697/CEP-HUJM/09
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators examined whether a written plus verbal preoperative counseling for patients undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting and pain.

Conditions

Vomiting; Nausea; Postoperative Pain; Feeling

Keywords

Vomiting; Nausea; Postoperative pain; Feeling

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  A questionnaire containing a visual analogue scale (VAS) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. The VAS consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. The patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. The VAS score of each individual was determined by measuring in millimeters from the left end of the line to the point marked.

  24h after operation

Secondary Outcomes (1)

• Episodes of vomiting

  During the first 24h after surgery

Study Arms (2)

Preoperative counseling

EXPERIMENTAL

The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.

Other: Preoperative counseling

Control

NO INTERVENTION

The control group received no preoperative counseling either oral or written.

Interventions

Preoperative counseling OTHER

The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.

Also known as: Preoperative information

Preoperative counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult age (18-65 years-old),
• both sexes and
• candidates for an elective open cholecystectomy

You may not qualify if:

• having diabetes mellitus,
• chronic kidney failure,
• chronic liver disease,
• serum bilirubin \> 2 mg/dL,
• body mass index (BMI) \> 35 kg/m2,
• American Anesthesiologists Association (ASA) score \> 3,
• gastro-esophageal reflux,
• gastroparesis or intestinal obstruction.
• Patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (\> 4 h) operative time were also excluded.

Sponsors & Collaborators

• Federal University of Mato Grosso: lead

Study Sites (1)

Hospital Universitario Julio Mullar

Cuiabá, Mato Grosso, 78000-000, Brazil

Location

MeSH Terms

Conditions

Vomiting; Nausea; Pain, Postoperative

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Jose Aguilar-Nascimento, MD, PhD

  Federal University of Mato Grosso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Professor

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

BR (1)